Medical device manufacturer

Data Medical Associates, Inc.

Data Medical Associates, Inc. holds 111 FDA 510(k) clearances across 46 product codes. Median elapsed review time is 35 days. openFDA lists no recall records naming the company.

Updated 11 August 2026 · ingest status · JSON

510(k) clearances: 111
Product codes: 46
Median review: 35 days
Recall records: 0

How does FDA spell Data Medical Associates, Inc.?

FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.

Which product codes does Data Medical Associates, Inc. file in?

46 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
Code	Device	Clearances	Median review	Latest
CIG	Diazo Colorimetry, Bilirubin	10	41 days	20 December 1995
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	6	34 days	29 May 1997
JIY	Photometric Method, Iron (Non-Heme)	5	41 days	15 November 1994
CEK	Biuret (Colorimetric), Total Protein	4	35 days	6 September 1994
CFR	Hexokinase, Glucose	4	18 days	3 October 1995
KHS	Enzymatic, Carbon-Dioxide	4	37 days	29 February 1996
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	3	32 days	9 September 1986
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	3	21 days	11 September 1986
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	3	39 days	18 March 1992
CGA	Glucose Oxidase, Glucose	3	24 days	20 October 1994
CHH	Enzymatic Esterase--Oxidase, Cholesterol	3	44 days	23 August 1995
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	3	32 days	26 September 1986
CIX	Bromcresol Green Dye-Binding, Albumin	3	44 days	1 March 1995
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	3	35 days	29 September 1986
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	3	29 days	16 September 1986
JFJ	Catalytic Methods, Amylase	3	15 days	20 February 1987
JIX	Calibrator, Multi-Analyte Mixture	3	22 days	8 October 1999
JPZ	Colorimetric Method, Gamma-Glutamyl Transpeptidase	3	29 days	1 July 1996
KNK	Acid, Uric, Uricase (Colorimetric)	3	44 days	26 September 1986
CFM	Bathophenanthroline, Colorimetry, Iron (Non-Heme)	2	24 days	23 May 1986
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	2	18 days	3 October 1986
CGX	Alkaline Picrate, Colorimetry, Creatinine	2	38 days	2 October 1986
CHJ	Mercuric Thiocyanate, Colorimetry, Chloride	2	31 days	16 October 1986
CIC	Cresolphthalein Complexone, Calcium	2	29 days	26 September 1986
CIJ	Saccharogenic, Amylase	2	62 days	11 March 1994

Showing the 25 they file in most, of 46.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

Has Data Medical Associates, Inc. had a recall?

openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved 2026-08-11T14:48:53Z

What has Data Medical Associates, Inc. cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)	Device	Code	Decision	Elapsed days
K993098	HDL-C/LDL-C CALIBRATOR, MODEL 1913-003	JIX	8 October 1999	22
K971113	DMA TRIGLYCERIDES PROCEDURES	CDT	29 May 1997	63
K961919	DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE	JPZ	1 July 1996	45
K955796	IRON CALIBRATOR & CALIBRATION VERIFICATION SET	JJX	29 February 1996	69
K955302	SERUM BICARBONATE/CARBON DIOXIDE	KHS	29 February 1996	101
K955300	TOTAL BILIRUBIN PROCEDURE	CIG	20 December 1995	30
K952437	DMA GLUCOSE HEXOKINASE U.V. PROCEDURE	CFR	3 October 1995	131
K946161	DMA TOTAL CHOLESTEROL PROCEDURE	CHH	23 August 1995	247
K946354	DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE	JMO	8 May 1995	129
K946355	DMA ALBUMIN PROCEDURE	CIX	1 March 1995	61

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

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